Thioridazine Hydrochloride

ANDA 88273, held by Ani Pharms. Thioridazine Hydrochloride.

As of Nov 15, 2026, ANDA 88273 (Thioridazine Hydrochloride), held by Ani Pharms, was first approved by FDA on Oct 3, 1983, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 3, 1983
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Oct 3, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Thioridazine Hydrochloride100MG · tablet;oral	Thioridazine Hydrochloride	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Jul 16, 1987	Supplement 14Manufacturing	Approved	None posted
Jul 16, 1987	Supplement 13Manufacturing	Approved	None posted
Nov 7, 1986	Supplement 10Manufacturing	Approved	None posted
Nov 7, 1986	Supplement 9Manufacturing	Approved	None posted
Nov 7, 1986	Supplement 8Manufacturing	Approved	None posted
Jun 29, 1984	Supplement 1Manufacturing	Approved	None posted
Jan 17, 1984	Supplement 4Manufacturing	Approved	None posted
Jan 17, 1984	Supplement 3Manufacturing	Approved	None posted
Dec 12, 1983	Supplement 2Manufacturing	Approved	None posted
Oct 3, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88273
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters